US FDA Approves Nucala for Adult COPD Treatment

PHILADELPHIA, PA, USA, May 22, 2025 - GSK plc has announced the US FDA's approval of Nucala (mepolizumab) as an additional treatment for adults with chronic obstructive pulmonary disease (COPD) who have an eosinophilic phenotype and are inadequately controlled. This decision is supported by results from the MATINEE and METREX phase III clinical trials, which demonstrated that mepolizumab significantly reduces the frequency of moderate to severe exacerbations compared to placebo in patients with this specific type of COPD.

COPD management focuses on preventing exacerbations, which are acute episodes that can lead to irreversible lung damage and increased risk of death. The trials indicated that adverse events were similar in both placebo and mepolizumab groups. Mepolizumab stands out as the only approved biologic treatment for patients with eosinophilic COPD, characterized by a blood eosinophil count (BEC) of at least 150 cells/µL. This measurement, obtained through a simple blood test, helps identify the risk of exacerbations due to type 2 inflammation.

In the United States, approximately 70% of COPD patients who do not adequately respond to inhaled triple therapy have a BEC of 150 cells/µL or higher. This translates to over a million individuals at risk of exacerbations, including those requiring emergency care or hospitalization, who could potentially benefit from adding mepolizumab to their treatment regimen.

Kaivan Khavandi, GSK’s Senior Vice President and Global Head of Respiratory, Immunology & Inflammation R&D, emphasized the significance of this approval. He noted that exacerbations are crucial predictors of future risk, particularly for patients needing hospital care, and expressed optimism that Nucala offers new hope for improved treatments for COPD patients with an eosinophilic phenotype.

Jean Wright, CEO of the COPD Foundation, highlighted the relentless challenge faced by COPD patients in managing exacerbations despite maintenance therapies. According to Wright, biologics such as mepolizumab are providing fresh optimism for those affected by COPD.

In the MATINEE and METREX trials, mepolizumab added to triple inhaled therapy resulted in a statistically significant reduction in the rate of moderate or severe exacerbations compared to placebo in patients with an eosinophilic phenotype. In the MATINEE trial, for instance, there was a notable reduction in exacerbations leading to emergency department visits or hospitalizations among patients receiving mepolizumab.

COPD-related hospitalizations pose a substantial challenge to the healthcare system, often resulting from acute exacerbations that necessitate urgent medical attention. This costly burden underscores the importance of effective treatment options like mepolizumab. While currently not approved for COPD treatment outside the US, regulatory reviews are ongoing in other regions, including China and Europe.

The MATINEE and METREX trials were rigorous phase III studies that evaluated the efficacy and safety of mepolizumab as an add-on to inhaled triple therapy. The studies included a diverse patient population with varying severities of COPD, emphasizing type 2 inflammation as determined by blood eosinophil counts.

COPD is a complex inflammatory lung disease affecting millions in the US, leading to frequent hospital visits and emergency care. Despite existing inhaled therapies, many patients continue to experience exacerbations, highlighting the need for new treatment approaches.

Nucala, a monoclonal antibody targeting interleukin-5 (IL-5), plays a pivotal role in treating IL-5 mediated diseases associated with type 2 inflammation. It is approved for use in multiple conditions in Europe and the US, showcasing its versatility in addressing type 2 inflammatory diseases.

GSK remains committed to advancing respiratory medicine, developing innovative treatments that aim to alter disease progression and improve the lives of patients with respiratory conditions like COPD.